Respiratory concerns have always been of significant interest within the medical world. Certainly, the lack of sufficient breathing capacity lends itself to various and myriad problems for patients. Whether it concerns chronic obstructive pulmonary disease (COPD), emphysema or other lung maladies (including lung cancer and resultant issues), asthma, allergies, failures of internal respiratory cycles, or even, to a more specific level, sudden infant death syndrome and its unknown causes, there has been a long-standing need to understand and, more importantly, develop proper treatment for such breathing problems. In particular, the ability to actually continuously and reliably monitor a subject patient's capability of expelling sufficient carbon dioxide levels (in relation, for instance, to the amount of oxygen inhaled) to indicate appropriate respiratory levels has been a significant concern.
Capnography is considered the measurement of the level of carbon dioxide (CO2) in relation to a patient's respiratory status. Infrared sensors have been typically utilized for such a purpose, particular since carbon dioxide absorbs infrared light particularly well. Thus, typically, capnographs measure infrared absorption within a patient's exhalation profile to determine the rate of carbon dioxide generation and/or expulsion as an indicator of patient ventilation and thus respiratory effectiveness. The information obtained from a capnographic measurement is sometimes presented as a series of waveforms representing the partial pressure of carbon dioxide in the patient's exhaled breath as a function of time. Such a measurement is not easily rendered, however, through the standard devices utilized today, at least in terms of definitive data integrity and reliability thereof. However, for monitoring purposes, capnography is considered to be a prerequisite for safe intubation and general anesthesia, as well as for correct ventilation management in other areas.
Capnographs are typically utilized in conjunction with the delivery of medicinal gas, oxygen, for instance, to treat certain breathing disorders. Oxygen (and like) masks are the preferred method of such delivery, whether to cover the subject patient's mouth or to deliver through cannulae within his or her nostrils, or both nose and mouth in terms of coverage and delivery (and, for that matter, receipt of exhaled carbon dioxide, as well). Such a pathway allows for inhalation and exhalation as needed for delivery of treatment (medicinal) gas and expulsion of the resultant carbon dioxide from the patient's respiratory system. Whether through an all-encompassing (mouth and nose covering, for example), mouth alone, or nose alone, such a method employs fluidic gaseous transport for such a purpose.
With these types of devices, in any event, there have been implemented, as noted above, capnography devices to monitor certain gas measurements in relation to such treatments. These prior devices are, however, limited in that they are typically provided within the gas line as a rather sizeable structure and generally capture momentary, and not continuous, results in such a manner. Likewise, as noted herein, such devices are connected through expensive cables (which are susceptible to breakage, downtime, and replacement at significant cost) that lead to a monitoring record device that itself is of significant cost and relies upon the reliability of the worn device, the cable connector, and the machinery therein itself to provide correct readings in relation to the measurements collected at the worn device level. Such devices, thus, if needed for any type of continuing monitoring purpose, must be moved with the subject patient. These devices, requiring a directly cable-connected monitor is extremely limited in terms of mobility, for obvious reasons, as the monitoring record device itself weighs a number of pounds, at least, and requires carrying if the patient requires continuous connection thereto. Even movement from, for example, a hospital bed to a restroom requires significant and cumbersome choreography lest the system be disconnected and then reconnected thereafter. If the patient desires greater mobility, or even desires the ability to utilize such a device at his or her home, either disconnection (when such connection is paramount for monitoring purposes, of course, at least potentially) or significant mobility configurations and actions would be necessary. Such is particularly necessary due to the rather delicate nature of such monitoring record devices; dropping such devices at any height could compromise if not disrupt entirely (for that matter, break) the capabilities of the record device to the extent that it is no longer useful and replacement (again, at significant cost) is needed. The same could be said for the cable connection as any rigorous activity undertaken in relation to such a component could effectively compromise its usefulness as well. And, as above, excessive costs are associated with such connection components if replacement is of necessity. In other words, then, the current state of the capnography art is limited significantly to such large, cumbersome, low-mobility (if at all) devices. Coupled with the fact that such a capnograph itself is typically rather large and connected to the breathing lines themselves, the care needed to ensure such a base device does not break during any activities would be of vital importance, as well. There exists a definite need to supplant such current devices, if not the entire system itself, to allow for greater mobility of patients, at least, and to permit improved measurement results, as well. The further ability to utilize data of great integrity in relation to such capnographic measurements, if not in terms of continuous, reliable results, for notification purposes as well as possible reliable predictive health status modeling, would be of significant extra benefit, too.
The current state of capnography devices and methods, unfortunately, as alluded to above, leaves much to be desired, particularly in terms of costs, limited monitoring intervals, cumbersome requirements in terms of potential mobility for a patient, and, perhaps most importantly, the lack of remote capabilities and, as a result, the inability to monitor multiple users through one data center simultaneously (and, furthermore, the lack of any real-time capabilities to provide predictive modeling for treatment potentials for such patients). In other words, the current methods employ capnograph devices that are provided along an oxygen line and record, within the confines of a “box” structure that itself is connected through at least one cable to an outside monitoring recorder for actual review of the patient's measured levels. Such a connection is made through a rather expensive cable (wire/cord) and the monitoring record device is limited to that specific patient and, perhaps more importantly, is provided itself within a rather large, heavy, and breakable structure. Although such a “standard” capnography system used nowadays has some degree of reliability for monitoring purposes, it remains problematic that such a device limits the range of mobility for a patient, at least. However, another particular important issue concerns the fact that such a current standard system also is limited to one capnograph per one monitoring device; there are no remote data processing capabilities that allow for a database to handle such capnogram data from multiple patients simultaneously. Additionally, however, the lack of provision of such a device within a smaller, confined area, let alone through a reliable transfer protocol other than via a cable that may fail or at least become damaged and require replacing is another significant drawback of such a “typical” system.
Additionally, the current capnograph technology does not provide any benefits that would be certainly of great interest for a potentially automated and fully enclosed system. There is lacking any definitive capability for on-line and automatic systems checks in order to ensure the entire device is functioning properly, both in terms of actual data capture capacity and data transfer realities. Likewise, there is no means provided within the state of the capnography art to accord definite date and time stamp data for captured and transferred data packets; at best, such systems merely capture data on the fly and send the same to a cable-connected single-person data base. There is nothing within the prior art disclosing a multi-patient capability with full data integrity capture, transfer, and back up. Furthermore, the current systems do not lend themselves to any predictive modeling potentials, wasting an opportunity to capture certain patient vital information that may be utilized to establish a future estimate as to such a specific patient's condition and suitable suggested treatment in relation thereto. In essence, the data related to the patient's respiratory levels (capnogram and/or waveform) are not provided in a sufficiently reliable manner and with such integrity as to permit such a predictive model to be established with any precision, at least not enough for risk-taking with such an artificial intelligence platform. Thus, there remains a noticeable need for such beneficial results within this specific medical realm, which the current monitoring systems are clearly lacking. The present invention provides such benefits and overcomes the deficiencies of the state of the capnography art.
Of particular difficulty has proven the potential for a system that not only allows for capnography measurements, but also utilizes such results for a reliable and direct operation of a drug delivery device in relation to such capnography measurements, specifically with such a system operated wirelessly between every component. There have been suggested wireless capnography devices in the prior art, albeit solely in terms of captured results within a single device, not in terms of utilizing more than one with the same waveform generating algorithm. There have also been suggested systems wherein a capnography device is utilized to transfer results to a drug delivery device for delivery purposes in response to such results. These systems, however, are limited to hospital or like room settings and typical delivery devices in place (such as IV towers, wall-mounted gas tank feeders, and the like). Likewise, such systems rely upon measured results primarily, not upon mirrored algorithms at different devices to ensure such capnography data is reliable and proper (or to ensure the system is actually operating properly itself). As such, these prior art systems lack the ability to, for instance, prevent outside hacking or other like possible detrimental situations since the results are developed at the capnography device itself or through a single algorithm location, lacking a means to ensure such data is proper and not compromised. To that end, the lack of such reliability lends itself to further difficulties in correlating drug delivery reliant upon such potentially suspect results, as well. As such, as noted above, these prior art systems have only been pondered, not integrated within the health industry. The present invention overcomes all of the prior deficiencies and problems associated with these earlier concepts.